AESKUSLIDES® ANCA Formalin
by Aesku.Diagnostics GmbH & Co. KG 2 variants
Ref 54.101
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-04250289503839 04250289503839 | Date11 Jun 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- Aeskuslides® Anca
- Model / Reference
- 54.101
- Primary DI / UDI-DI
- 04250289503839
- Basic UDI-DI
- B-04250289503839
- EMDN Code
- W0102100401 Anca screening
- Device Class
- Class IVD General
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000026925
Other devices from AESKU.DIAGNOSTICS GmbH&Co.KG
Properties
Other properties (7)
- Sterile: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No